UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043875 |
|---|---|
| Receipt number | R000050089 |
| Scientific Title | Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/09 06:25:21 |
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Basic information
Public title
Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Acronym
Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Scientific Title
Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Scientific Title:Acronym
Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Region
| Asia(except Japan) |
Condition
Condition
at baseline, post-intervention and 3 month follow-up
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to confirm the PE interventions effect and its combination with therapeutic exercise, the authors believed it was imperative to conduct a randomized clinical trial where education plus stabilization training (knee- hip- and trunk-focused exercise) was compared with ST alone in PFP patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain
Key secondary outcomes
function, pain catastrophizing, kinesiophobia, and muscle strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
education plus stabilization training (ST) (knee- hip- and trunk-focused exercise)
Interventions/Control_2
ST alone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 14 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persian-native male and female, aged between 18 and 40 years, primary complaint of the anterior knee and the symptoms of PFP, anterior knee pain of 3 or greater on the 10-cm visual analogue scale (VAS) for a minimum of 8 weeks before participation, anterior knee pain when performing at least two of the following activities: prolonged sitting, squatting, kneeling, running, climbing and descending stairs
Key exclusion criteria
surgery and /or intra-articular pathology in any lower limb joint, patellar instability, knee joint effusion, Osgood-Schlatter or SindingLarsen-Johansson syndrome, referred pain coming from the lumbar spine, hips, ankles, or feet, and having physiotherapy treatment for PFP up to 3 months before participating
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Pouya |
| Middle name | |
| Last name | Rabiei |
Organization
Kharazmi university
Division name
Sport medicine
Zip code
6664743
Address
tehran
TEL
00989195394692
pouya.rabiei.pr@gmail.com
Public contact
Name of contact person
| 1st name | amir |
| Middle name | |
| Last name | letafatkar |
Organization
Kharazmi University
Division name
sport medicine
Zip code
6664743
Address
tehran
TEL
00989357465993
Homepage URL
letafatkaramir@yahoo.com
Sponsor or person
Institute
Kharazmi university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kharazmi university
Address
teran-mofateh
Tel
00982122258084
ha.123466@yahoo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050089
